Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were enrolled at 70 study sites in the United States and Europe. The first participant was screened on 29 July 2003; the last participant was randomized on 16 January 2004; the last participant observation for the primary endpoint analysis was 11 February 2005; the last participant last visit for end of study analysis was 10 June 2009.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participant Flow for 2 periods

Period 1: Randomized Phase

EFV+FTC+TDF

CBV+EFV

STARTED

257
[1]

254
[2]

COMPLETED

187

166

NOT COMPLETED

70

88

Lost to Follow-up

26

33

Adverse Event

10

10

Withrawal of consent

10

18

Sub-optimal virological response

3

13

Noncompliance

8

4

Protocol Violation

2

0

Pregnancy

3

1

Death

1

3

Hepatitis C treatment contraindicated

0

1

Inability to swallow pills

0

1

Incarceration

3

2

Moved out of State

0

1

Baseline NNRTI resistance mutations

4

0

High Hepatitis B DNA

0

1

[1]

Intention to treat (ITT) population N=255 (2 participants had received prior antiretroviral therapy)

[2]

ITT analysis population

Period 2: Atripla Phase

EFV+FTC+TDF

CBV+EFV

STARTED

160
[1]

126
[1]

COMPLETED

142

106

NOT COMPLETED

18

20

Adverse Event

2

1

Lost to Follow-up

5

7

Pregnancy

0

1

Death

0

2

Withdrew consent

7

7

Sub-optimal virological response

0

1

Non-compliance

1

0

Not specified

3

1

[1]

Number of participants who completed randomized phase and opted to roll over to Atripla at Week 144

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
The PI may publish study results 2 years after the completion of the study or earlier with the advance written permission of Gilead. The PI will submit any proposed publication or presentation of study results together with the name of the proposed scientific journal, forum or confeence to Gilead prior to submission or presentation (30 days prior for manuscripts and 15 days for abstracts and oral presentations).